Carious TeethpulpotomyNCT04345263
Outcome of Full Pulpotomy Using Calcium Silicate Based Materials
A study testing MTA pulpotomy in people with Carious Teeth, run by Jordan University of Science and Technology at 2 sites in Jordan.
Trial summary
Permanent teeth with carious pulp exposure and indicated for full pulpotomy will be treated using three different materials using aseptic technique and will be subsequently followed up clinically and radiographically at 6 months, 1 year and yearly up to 5 years. Read more about this study
- Who is it for?
- Ages 16 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Carious Teeth
- What is being tested?
- MTA pulpotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesJordan
- Study dates
- 1 Sep 2017to 2 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Mature permanent tooth with carious lesion exposing the pulp,
- Positive response to cold test
- Clinical Diagnosis of reversible or irreversible pulpitis
- Restorable tooth by direct restoration or crown
- Healthy patient
Who cannot join
- Non vital teeth
- Teeth without pulp exposure
- Inability to achieve hemostasis within 10 min after pulpotomy
- Non restorable teeth or teeth that require post and core restoration
Trial locations and contacts
2 sites in 1 country.
Jordan2 sites
Dental teaching centre Faculty Of Dentistry
Irbid, 21110
Jordan University of science and technology
Irbid, 22110
About this study
Official title: Outcome of Full Pulpotomy in Permanent Teeth With Carious Pulp Exposure, a Randomized Clinical Trial
Permanent teeth with carious pulp exposure and indicated for full pulpotomy will be treated using three different materials using aseptic technique and will be subsequently followed up clinically and radiographically at 6 months, 1 year and yearly up to 5 years.
Read the detailed description
- The target sample size is 150 patients medically fit, having vital teeth with carious pulp exposure and complaining of pain.
- The patients tooth will receive full pulpotomy under aseptic conditions and it will be randomly assigned to one of 3 calcium silicate based materials namely, (Mineral trioxide Aggregate (MTA), Biodentine, and Bioceramic for capping the full pulpotomy followed by resin composite restoration.
- Follow up for pain levels will be done during the first week.
- clinical and radiographic examination will be done at 6 months, 1 year and yearly up to 5 years.
- Success of the procedure includes absence of clinical signs and symptoms, with absence of pathology in the root and periapex on periapical radiographs.
- The 3 materials will be compared in terms of clinical and radiographic outcomes.
- demographic data of the three groups will be also compared
- predictive factors of success will be also analyzed
- tooth color changes will be also measured using vita easy shade and will compared between the groups at 6 months and 1 year.
- Conditions
- Carious Teeth
- Being tested
- MTA pulpotomy
- Keywords
- teeth, caries, pulpotomy, MTA, biodentine, bioceramic
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MTA pulpotomyProcedure or surgery
Also called Biodentine pulpotomy and Bioceramic pulpotomy
Cutting the coronal portion of the pulp to the level of canal orifices and applying the dressing and restoration
| Study group | Role | What they receive |
|---|---|---|
| MTA pulpotomy | Active comparator | Tooth will receive MTA \& resin composite restoration Receives: Procedure: MTA pulpotomy |
| Biodentine pulpotomy | Active comparator | Tooth will receive Biodentine \& resin composite restoration Receives: Procedure: MTA pulpotomy |
| Bioceramic pulpotomy | Active comparator | Tooth will receive Bioceramic \& resin composite restoration Receives: Procedure: MTA pulpotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of pain relief after treatment compared to preoperative pain level
Absence of symptoms or significant pain reduction within the first week after treatment as measured on a numerical scale from 0 to 10 where zero means no pain and 10 is the most sever pain. Visual analogue scale will be also used.
Measured: 1 week
Secondary outcomes (1)
Radiographic normalcy
Absence of pathology in the root and the bone surrounding the apex
Measured: 1 year and yearly up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2020
- Study start1 Sep 2017
- Primary completion2 May 2018
- Study completion2 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carious TeethStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jordan University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nessrin Taha, DCD, Study chair, Jordan University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04345263
- Sponsor's protocol ID
- 503/2017
- Acronym
- pulpotomy
- Status last verified
- May 2024
- First submitted
- 9 Apr 2020
- Last updated
- 2 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Detailed participants data will be released within the publications resulting from the trial with reference to the registration number of the study. If further details are required the principal investigator. can be contacted via email.
Publications
Taha NA, Al-Rawash MH, Imran ZA. Outcome of full pulpotomy in mature permanent molars using 3 calcium silicate-based materials: A parallel, double blind, randomized controlled trial. Int Endod J. 2022 May;55(5):416-429. doi: 10.1111/iej.13707. Epub 2022 Mar 17.
PubMed 35152464
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of Full Pulpotomy in Permanent Teeth With Carious Pulp Exposure, a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04345263
- Acronym / sponsor ID
- pulpotomy / 503/2017
- Conditions
- Carious Teeth
- Keywords
- teeth, caries, pulpotomy, MTA, biodentine, bioceramic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Jordan University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 2 May 2018 (actual)
- Study completion
- 2 May 2024 (estimated)
- First posted
- 14 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Permanent teeth with carious pulp exposure and indicated for full pulpotomy will be treated using three different materials using aseptic technique and will be subsequently followed up clinically and radiographically at 6 months, 1 year and yearly up to 5 years.
Detailed description
- The target sample size is 150 patients medically fit, having vital teeth with carious pulp exposure and complaining of pain.
- The patients tooth will receive full pulpotomy under aseptic conditions and it will be randomly assigned to one of 3 calcium silicate based materials namely, (Mineral trioxide Aggregate (MTA), Biodentine, and Bioceramic for capping the full pulpotomy followed by resin composite restoration.
- Follow up for pain levels will be done during the first week.
- clinical and radiographic examination will be done at 6 months, 1 year and yearly up to 5 years.
- Success of the procedure includes absence of clinical signs and symptoms, with absence of pathology in the root and periapex on periapical radiographs.
- The 3 materials will be compared in terms of clinical and radiographic outcomes.
- demographic data of the three groups will be also compared
- predictive factors of success will be also analyzed
- tooth color changes will be also measured using vita easy shade and will compared between the groups at 6 months and 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MTA pulpotomy | Active comparator | Procedure: MTA pulpotomyTooth will receive MTA \& resin composite restoration |
| Biodentine pulpotomy | Active comparator | Procedure: MTA pulpotomyTooth will receive Biodentine \& resin composite restoration |
| Bioceramic pulpotomy | Active comparator | Procedure: MTA pulpotomyTooth will receive Bioceramic \& resin composite restoration |
Who may qualify
- Ages
- 16 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Mature permanent tooth with carious lesion exposing the pulp,
- Positive response to cold test
- Clinical Diagnosis of reversible or irreversible pulpitis
- Restorable tooth by direct restoration or crown
- Healthy patient
Key exclusion criteria (4 listed)
- Non vital teeth
- Teeth without pulp exposure
- Inability to achieve hemostasis within 10 min after pulpotomy
- Non restorable teeth or teeth that require post and core restoration
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MTA pulpotomyAlso: Biodentine pulpotomy and Bioceramic pulpotomyCutting the coronal portion of the pulp to the level of canal orifices and applying the dressing and restoration | Procedure or surgery | Bioceramic pulpotomy, Biodentine pulpotomy, MTA pulpotomy |
Primary outcome
Degree of pain relief after treatment compared to preoperative pain level
Time frame: 1 week
Absence of symptoms or significant pain reduction within the first week after treatment as measured on a numerical scale from 0 to 10 where zero means no pain and 10 is the most sever pain. Visual analogue scale will be also used.
1 secondary outcome
Radiographic normalcy
Time frame: 1 year and yearly up to 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2024.
- Derived from this study: PubMed 35152464Taha NA, Al-Rawash MH, Imran ZA. Outcome of full pulpotomy in mature permanent molars using 3 calcium silicate-based materials: A parallel, double blind, randomized controlled trial. Int Endod J. 2022 May;55(5):416-429. doi: 10.1111/iej.13707. Epub 2022 Mar 17.
- Individual participant dataSharing planned: No. Detailed participants data will be released within the publications resulting from the trial with reference to the registration number of the study. If further details are required the principal investigator. can be contacted via email.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nessrin Taha, DCD study chair
Jordan University of Science and Technology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MTA pulpotomy in people with Carious Teeth, run by Jordan University of Science and Technology at 2 sites in Jordan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of pain relief after treatment compared to preoperative pain level (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04345263, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2024.